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CTRP_Registry_Batch_Upload_Template

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CTRP_Registry_Batch_Upload_Template Powered By Docstoc
					CTRP Trial Registration Batch Upload Specification for Complete Trials (valid as of 3.3 r

I. Getting ready to send the batch file
1. Prior to your initial batch submission please contact NCI Apps Support to gain approval to send batch files t
Please provide your login name, first and last names and email address stored in your CTRP profile.
1a. CTRP Application Support may be reached at ncictro@mail.nih.gov
1b. Once step 1a has been accomplished you will no longer need to contact Apps Support prior to sending subs
2. Access the NCI Trial Registration application batch upload web page (at https://trials.nci.nih.gov/registry/a
2a. An Excel spreadsheet (.xls) containing mandatory and optional data for the trial(s)
2b. A separate zip file containing applicable trial documents (e.g. Protocol; IRB approval; Informed Consent; P


II. Instructions for preparing the trial data file
1. The trial elements required for registration should be listed in the order specified in the Batch Upload Data
2. Each trial should be uniquely identified (this can be your cancer center unique trial identifier)
3. This version of the spec:
1) Supports only interventional trials
2) Supports only complete (Summary 4 Funding Sponsor Category is 'National', 'Externally Peer-Reviewed' or
3) Supports amendment to complete CTRP trials with 'Abstraction Verified Response' and 'Abstraction Verifie
4) Supports update to complete CTRP trials with processing status 'Accepted' and above.
5) Supports up to 100 trials per data file
6) Supports multiple grants per submitted trial
7) Supports multiple IND/IDE per submitted trial
8) Supports generic contact for Responsible Party - Sponsor
9) Supports multiple 'other' trial identifier.
10) Supports 2 options of data submission for the case when XML for trial submission to ClinicalTrials.gov is r
11) Supports 2 options of providing person and organization related information: PO-ID for the person or orga
12) List of CTRP persons and organizations along with PO-ID can be requested from CTRO at ncictro@mail.ni
Also PO-ID for a person and an organization can be found when using appropriate look-up on the Register Tria

New in 3.3 release
1). Modified definition of trial category. New trial category is based on Summary 4 Funding Sponsor/Source Ca
2) Modified list of values for Summary 4 Funding Sponsor/Source Category.
3) Summary 4 Funding Sponsor/Source information is mandatory.
4) 'Exempt Indicator' attribute is added to the list of IND/IDE attributes.
5) Phase and Primary Purpose assignment is modified.
6) List of values for Phase is modified.
7) List of values for Primary Purpose is modified.


III. Instructions for preparing the trial documents zip file
1. Rename the document files if names are not unique for avoiding files replacement at compressing.
Ex: prefix files with unique trial identifier XXXX_document_name.document_extension.
2. Make sure each of the document file names prefixed with trial identifiers are unique per trial if prefixing is u
3. Provide the document names (incl. extension) in the file containing the trial data. Up to 7 files can be specifi
4. Zip all trial-related documents. Please do not include any pathname in the zip file.

Note: Please note that some elements will be ignored at update submission to existing CTRP trials.
s (valid as of 3.3 release)


al to send batch files to CTRP.
TRP profile.

t prior to sending subsequent batch files
nci.nih.gov/registry/admin/batchUpload.action) where sites may upload:

; Informed Consent; Participating Sites; Change Memo) for the trials in the data file



he Batch Upload Data Element Spec tab in this spreadsheet




 lly Peer-Reviewed' or 'Institutional') trials submission
nd 'Abstraction Verified No Response' processing statuses




 ClinicalTrials.gov is required and when XML is not required.
 for the person or organization or the set of mandatory attributes for person or organization.
RO at ncictro@mail.nih.gov.
up on the Register Trial screen without need to record trial.


ng Sponsor/Source Category/Type.




ompressing.

er trial if prefixing is used.
o 7 files can be specified in one single trial record


TRP trials.
Trial elements Order   Trial data element                Required for original
                                                         submission

1                      Unique Trial Identifier           Yes
2                      Submission Type                   Yes




3                      NCI Trial Identifier




4                      ClinicalTrials.gov XML Required? Yes




5                      Amendment Number



6                      Amendment Date




7                      Lead Organization Trial Identifier Yes
8    NCT


9    Other Trial Identifier


10   Title                          Yes




11   Trial Type                     Yes




12   Primary Purpose                Yes




13   [Primary Purpose] Additional   Yes if Primary Purpose is 'Other'
     Qualifier

14   [Primary Purpose] Other Text   Yes if Primary Purpose is 'Other'

15   Phase                          Yes

16   Pilot Trial?

17   [Sponsor] Organization PO-ID   PO-ID or all mandatory
                                    organization attributes are not
                                    NULL AND if ‘ClinicalTrials.gov
                                    XML Required?”=’Yes’
18   [Sponsor] Organization Name    Yes if Sponsor’s PO-ID is NULL
                                    AND if ‘ClinicalTrials.gov XML
                                    Required?”=’Yes’
19   [Sponsor] Street Address       Yes if Sponsor’s PO-ID is NULL
                                    AND if ‘ClinicalTrials.gov XML
                                    Required?”=’Yes’
20   [Sponsor] City                 Yes if Sponsor’s PO-ID is NULL
                                    AND if ‘ClinicalTrials.gov XML
                                    Required?”=’Yes’
21   [Sponsor] State/Province        Yes for US/Canada/Australia Yes
                                     if Sponsor’s PO-ID is NULL AND
                                     if ‘ClinicalTrials.gov XML
                                     Required?”=’Yes’ and for
                                     US/Canada/Australia
22   [Sponsor] Zip/Postal code       Yes if Sponsor’s PO-ID is NULL
                                     AND if ‘ClinicalTrials.gov XML
                                     Required?”=’Yes’
23   [Sponsor] Country               Yes if Sponsor’s PO-ID is NULL
                                     AND if ‘ClinicalTrials.gov XML
                                     Required?”=’Yes’
24   [Sponsor] Email Address         Yes if Sponsor’s PO-ID is NULL
                                     AND if ‘ClinicalTrials.gov XML
                                     Required?”=’Yes’
25   [Sponsor] Phone


26   [Sponsor] TTY
27   [Sponsor] FAX
28   [Sponsor] URL
29   Responsible Party               Yes if ClinicalTrials.gov XML
                                     Required? is set to 'Yes'

30   Sponsor Contact Type            Yes if ‘ClinicalTrials.gov XML
                                     Required?”=’Yes’ and if
                                     Responsible Party is Sponsor

31   [Sponsor Contact] Title        Yes if ‘ClinicalTrials.gov XML
                                    Required?”=’Yes’ and if
                                    Responsible Party is Sponsor
                                    and Sponsor Contact Type is
                                    'Generic'
32   [Sponsor Contact] Person PO-ID Yes if ‘ClinicalTrials.gov XML
                                    Required?”=’Yes’ and if
                                    Responsible Party is Sponsor
                                    and Sponsor Contact Type is
                                    'Personal'. Sponsor’s Contact PO-
                                    ID or all person-specific
                                    mandatory attributes must be
                                    provided
33   [Sponsor Contact] First Name   Yes if ‘ClinicalTrials.gov XML
                                    Required?”=’Yes’ and if
                                    Responsible Party is Sponsor
                                    and Sponsor Contact Type is
                                    'Personal' and Sponsor’s Contact
                                    PO-ID is NULL
34   [Sponsor Contact] Middle Name
35   [Sponsor Contact] Last Name      Yes if ‘ClinicalTrials.gov XML
                                      Required?”=’Yes’ and if
                                      Responsible Party is Sponsor
                                      and Sponsor Contact Type is
                                      'Personal' and Sponsor’s Contact
                                      PO-ID is NULL
36   [Sponsor Contact] Street Address Yes if ‘ClinicalTrials.gov XML
                                      Required?”=’Yes’ and if
                                      Responsible Party is Sponsor
                                      and Sponsor Contact Type is
                                      'Personal' and Sponsor’s Contact
                                      PO-ID is NULL
37   [Sponsor Contact] City           Yes if ‘ClinicalTrials.gov XML
                                      Required?”=’Yes’ and if
                                      Responsible Party is Sponsor
                                      and Sponsor Contact Type is
                                      'Personal' and Sponsor’s Contact
                                      PO-ID is NULL
38   [Sponsor Contact] State/Province Yes if ‘ClinicalTrials.gov XML
                                      Required?”=’Yes’ and if
                                      Responsible Party is Sponsor
                                      and Sponsor Contact Type is
                                      'Personal' and Sponsor’s Contact
                                      PO-ID is NULL and for USA,
                                      Canada or Australia
39   [Sponsor Contact] Zip/Postal     Yes if ‘ClinicalTrials.gov XML
     code                             Required?”=’Yes’ and if
                                      Responsible Party is Sponsor
                                      and Sponsor Contact Type is
                                      'Personal' and Sponsor’s Contact
                                      PO-ID is NULL
40   [Sponsor Contact] Country        Yes if ‘ClinicalTrials.gov XML
                                      Required?”=’Yes’ and if
                                      Responsible Party is Sponsor
                                      and Sponsor Contact Type is
                                      'Personal' and Sponsor’s Contact
                                      PO-ID is NULL
41   [Sponsor Contact] Email Address Yes if ‘ClinicalTrials.gov XML
                                      Required?”=’Yes’ and if
                                      Responsible Party is Sponsor
                                      and Sponsor Contact Type is
                                      'Personal' and Sponsor’s Contact
                                      PO-ID is NULL
42   [Sponsor Contact] Phone          Yes if ‘ClinicalTrials.gov XML
                                      Required?”=’Yes’ and if
                                      Responsible Party is Sponsor
                                      and Sponsor Contact Type is
                                      'Personal' and Sponsor’s Contact
                                      PO-ID is NULL
43   [Sponsor Contact] TTY
44   [Sponsor Contact] FAX
45   [Sponsor Contact] URL
46   [Lead Organization] Organization PO-ID or all mandatory
     PO-ID                            organization specific attribute are
                                      required
47   [Lead Organization] Name         Yes if Lead Organization PO-ID is
                                      NULL
48   [Lead Organization] Street       Yes if Lead Organization PO-ID is
     Address                          NULL


49   [Lead Organization] City            Yes if Lead Organization PO-ID is
                                         NULL
50   [Lead Organization]                 Yes for US/Canada/Australia and
     State/Province                      if Lead Organization PO-ID is
                                         NULL

51   [Lead Organization] Zip/Postal      Yes if Lead Organization PO-ID is
     code                                NULL
52   [Lead Organization] Country         Yes if Lead Organization PO-ID is
                                         NULL
53   [Lead Organization] Email           Yes if Lead Organization PO-ID is
     Address                             NULL
54   [Lead Organization] Phone


55   [Lead Organization] TTY
56   [Lead Organization] FAX
57   [Lead Organization] URL
58   [Lead Organization] Organization
     Type
59   [Principal Investigator] Person PO- PO-ID or all person-specific
     ID                                  mandatory attributes
60   [Principal Investigator] First Name Yes if Principal Investigator PO-
                                         ID is NULL
61   [Principal Investigator] Middle
     Name
62   [Principal Investigator] Last Name Yes if Principal Investigator PO-
                                         ID is NULL
63   [Principal Investigator] Street     Yes if Principal Investigator PO-
     Address                             ID is NULL


64   [Principal Investigator] City       Yes if Principal Investigator PO-
                                         ID is NULL

65   [Principal Investigator]            Yes for US/Canada/Australia and
     State/Province                      if Principal Investigator PO-ID is
                                         NULL
66   [Principal Investigator] Zip/Postal Yes if Principal Investigator PO-
     code                                ID is NULL

67   [Principal Investigator] Country    Yes if Principal Investigator PO-
                                         ID is NULL

68   [Principal Investigator] Email      Yes if Principal Investigator PO-
     Address                             ID is NULL
69   [Principal Investigator] Phone      Yes if Principal Investigator PO-
                                         ID is NULL


70   [Principal Investigator] TTY
71   [Principal Investigator] FAX
72   [Principal Investigator] URL
73   Summary 4 Funding Category          Yes

74   [Summary 4 Funding                  PO-ID or all mandatory
     Sponsor/Source] Organization        organization specific attribute are
     PO-ID                               required
75   [Summary 4 Funding                  Yes if Organization PO-ID is
     Sponsor/Source] Organization        NULL
     Name
76   [Summary 4 Funding                  Yes if Organization PO-ID is
     Sponsor/Source] Street Address      NULL

77   [Summary 4 Funding              Yes if Organization PO-ID is
     Sponsor/Source] City            NULL
78   [Summary 4 Funding              Yes if Organization PO-ID is
     Sponsor/Source] State/Province  NULL and for
                                     US/Canada/Australia
79   [Summary 4 Funding              Yes if Organization PO-ID is
     Sponsor/Source] Zip/Postal code NULL

80   [Summary 4 Funding                  Yes if Organization PO-ID is
     Sponsor/Source ] Country            NULL
81   [Summary 4 Funding                  Yes if Organization PO-ID is
     Sponsor/Source ] Email Address      NULL

82   [Summary 4 Funding
     Sponsor/Source ] Phone

83   [Summary 4 Funding
     Sponsor/Source ] TTY
84   [Summary 4 Funding
     Sponsor/Source ] FAX
85   [Summary 4 Funding
     Sponsor/Source ] URL
86   Program Code
87   [NIH Grant] Funding Mechanism     Yes: if NIH grant exists


88   [NIH Grant] Institute Code        Yes: if NIH grant exists


89   [NIH Grant] Serial Number         Yes: if NIH grant exists


90   [NIH Grant] NCI Division/Program Yes: if NIH grant exists
     Code




91   Current Trial Status              Yes




92   Why Study Stopped?                Yes if Current Trial Status is
                                       Withdrawn, Temporarily Closed
                                       to Accrual, Temporarily Closed to
                                       Accrual and Intervention or
                                       Administratively Complete

93   Current Trial Status Date         Yes

94   Study Start Date                  Yes
95    Study Start Date Type          Yes




96    Primary Completion Date        Yes




97    Primary Completion Date Type   Yes




98    IND/IDE Type                   Yes: if IND/IDE trial


99    IND/IDE Number                 Yes: if IND/IDE trial


100   IND/IDE Grantor                Yes: if IND/IDE trial


101   IND/IDE Holder Type            Yes: if IND/IDE trial
102   [IND/IDE] NIH Institution         Yes If IND/IDE trial AND
                                        (IND/IDE Holder Type) = NIH




103   [IND/IDE] NCI Division /Program   Yes if IND/IDE trial AND If
                                        (IND/IDE Holder Type) = NCI




104   [IND/IDE] Has Expanded            Yes if IND/IDE trial
      Access?

105   [IND/IDE] Expanded Access         If (Has Expanded Access?) =
      Status                            Yes




106   [IND/IDE] Exempt Indicator        Yes


107   Oversight Authority Country      Yes if ClinicalTrials.gov XML
                                       Required? is set to 'Yes'
108   Oversight Authority Organization Yes ClinicalTrials.gov XML
      Name                             Required? is set to 'Yes'
109   FDA Regulatory Information       Yes ClinicalTrials.gov XML
      Indicator                        Required? is set to 'Yes'

110   Section 801 Indicator             Yes if FDA Regulatory
                                        Information Indicator is 'Yes' and
                                        ClinicalTrials.gov XML Required?
                                        is set to 'Yes'
111   Delayed Posting Indicator         Yes if section 801 Indicator is
                                        'Yes' and ClinicalTrials.gov XML
                                        Required? is set to 'Yes'



112   Data Monitoring Committee
      Appointed Indicator


113   Protocol Document File Name       Yes
114   IRB Approval Document File          Yes
      Name




115   Participating Sites Document File
      Name




116   Informed Consent Document File
      Name




117   Other Trial Related Document
      File Name


118   Change Memo Document Name




119   Protocol Highlight Document
      Name
Required for amendment Required for update   Valid Values



Yes                     Yes
Yes                     Yes                  O, A, U




Yes                     Yes




Yes                                          Yes, No




Yes




Yes
Yes                                                                     Max 4000 characters




Yes                                 Yes                                 Interventional, Observational




Yes                                 Yes                                 Treatment, Prevention,
                                                                        Supportive Care, Screening,
                                                                        Diagnostic, Health Service
                                                                        Research, Basic Science, Other

Yes if Primary Purpose is 'Other'   Yes if Primary Purpose is 'Other'   Other


Yes if Primary Purpose is 'Other'   Yes if Primary Purpose is 'Other'

Yes                                 Yes                                 0, I, I/II, II, II/III, III, IV, NA,

                                                                        Yes, No

PO-ID or all mandatory
organization attributes are not
NULL AND if ‘ClinicalTrials.gov
XML Required?”=’Yes’
Yes if Sponsor’s PO-ID is NULL
AND if ‘ClinicalTrials.gov XML
Required?”=’Yes’
Yes if Sponsor’s PO-ID is NULL
AND if ‘ClinicalTrials.gov XML
Required?”=’Yes’
Yes if Sponsor’s PO-ID is NULL
AND if ‘ClinicalTrials.gov XML
Required?”=’Yes’
Yes for US/Canada/Australia Yes                                    2-letter state/province code
if Sponsor’s PO-ID is NULL AND                                     required for US/Canada, 2-3
if ‘ClinicalTrials.gov XML                                         letter code required for Australia
Required?”=’Yes’ and for
US/Canada/Australia
Yes if Sponsor’s PO-ID is NULL
AND if ‘ClinicalTrials.gov XML
Required?”=’Yes’
Yes if Sponsor’s PO-ID is NULL                                     3-letter country code required
AND if ‘ClinicalTrials.gov XML
Required?”=’Yes’
Yes if Sponsor’s PO-ID is NULL
AND if ‘ClinicalTrials.gov XML
Required?”=’Yes’




Yes if ClinicalTrials.gov XML                                      PI, Sponsor
Required? is set to 'Yes'

Yes if ‘ClinicalTrials.gov XML    Yes if ‘ClinicalTrials.gov XML    Personal, Generic
Required?”=’Yes’ and if           Required?”=’Yes’ and if
Responsible Party is Sponsor      Responsible Party value is
                                  Sponsor
Yes if ‘ClinicalTrials.gov XML    Yes if ‘ClinicalTrials.gov XML
Required?”=’Yes’ and if           Required?”=’Yes’ and if
Responsible Party is Sponsor      Responsible Party is Sponsor
and Sponsor Contact Type is       and Sponsor Contact Type is
'Generic'                         'Generic'
Yes if ‘ClinicalTrials.gov XML    Yes if ‘ClinicalTrials.gov XML
Required?”=’Yes’ and if           Required?”=’Yes’ and if
Responsible Party is Sponsor      Responsible Party is Sponsor
and Sponsor Contact Type is       and Sponsor Contact Type is
'Personal'. Sponsor’s Contact PO- 'Personal'. Sponsor’s Contact PO-
ID or all person-specific         ID or all person-specific
mandatory attributes must be      mandatory attributes must be
provided                          provided
Yes if ‘ClinicalTrials.gov XML    Yes if ‘ClinicalTrials.gov XML
Required?”=’Yes’ and if           Required?”=’Yes’ and if
Responsible Party is Sponsor      Responsible Party is Sponsor
and Sponsor Contact Type is       and Sponsor Contact Type is
'Personal' and Sponsor’s Contact 'Personal' and Sponsor’s Contact
PO-ID is NULL                     PO-ID is NULL
Yes if ‘ClinicalTrials.gov XML     Yes if ‘ClinicalTrials.gov XML
Required?”=’Yes’ and if            Required?”=’Yes’ and if
Responsible Party is Sponsor       Responsible Party is Sponsor
and Sponsor Contact Type is        and Sponsor Contact Type is
'Personal' and Sponsor’s Contact   'Personal' and Sponsor’s Contact
PO-ID is NULL                      PO-ID is NULL
Yes if ‘ClinicalTrials.gov XML     Yes if ‘ClinicalTrials.gov XML
Required?”=’Yes’ and if            Required?”=’Yes’ and if
Responsible Party is Sponsor       Responsible Party is Sponsor
and Sponsor Contact Type is        and Sponsor Contact Type is
'Personal' and Sponsor’s Contact   'Personal' and Sponsor’s Contact
PO-ID is NULL                      PO-ID is NULL
Yes if ‘ClinicalTrials.gov XML     Yes if ‘ClinicalTrials.gov XML
Required?”=’Yes’ and if            Required?”=’Yes’ and if
Responsible Party is Sponsor       Responsible Party is Sponsor
and Sponsor Contact Type is        and Sponsor Contact Type is
'Personal' and Sponsor’s Contact   'Personal' and Sponsor’s Contact
PO-ID is NULL                      PO-ID is NULL
Yes if ‘ClinicalTrials.gov XML     Yes if ‘ClinicalTrials.gov XML     2-letter state/province code
Required?”=’Yes’ and if            Required?”=’Yes’ and if            required for US/Canada, 2-3
Responsible Party is Sponsor       Responsible Party is Sponsor       letter code required for Australia
and Sponsor Contact Type is        and Sponsor Contact Type is
'Personal' and Sponsor’s Contact   'Personal' and Sponsor’s Contact
PO-ID is NULL and for USA,         PO-ID is NULL and for USA,
Canada or Australia                Canada or Australia
Yes if ‘ClinicalTrials.gov XML     Yes if ‘ClinicalTrials.gov XML
Required?”=’Yes’ and if            Required?”=’Yes’ and if
Responsible Party is Sponsor       Responsible Party is Sponsor
and Sponsor Contact Type is        and Sponsor Contact Type is
'Personal' and Sponsor’s Contact   'Personal' and Sponsor’s Contact
PO-ID is NULL                      PO-ID is NULL
Yes if ‘ClinicalTrials.gov XML     Yes if ‘ClinicalTrials.gov XML     3-letter country code required
Required?”=’Yes’ and if            Required?”=’Yes’ and if
Responsible Party is Sponsor       Responsible Party is Sponsor
and Sponsor Contact Type is        and Sponsor Contact Type is
'Personal' and Sponsor’s Contact   'Personal' and Sponsor’s Contact
PO-ID is NULL                      PO-ID is NULL
Yes if ‘ClinicalTrials.gov XML     Yes if ‘ClinicalTrials.gov XML
Required?”=’Yes’ and if            Required?”=’Yes’ and if
Responsible Party is Sponsor       Responsible Party is Sponsor
and Sponsor Contact Type is        and Sponsor Contact Type is
'Personal' and Sponsor’s Contact   'Personal' and Sponsor’s Contact
PO-ID is NULL                      PO-ID is NULL
Yes if ‘ClinicalTrials.gov XML     Yes if ‘ClinicalTrials.gov XML
Required?”=’Yes’ and if            Required?”=’Yes’ and if
Responsible Party is Sponsor       Responsible Party is Sponsor
and Sponsor Contact Type is        and Sponsor Contact Type is
'Personal' and Sponsor’s Contact   'Personal' and Sponsor’s Contact
PO-ID is NULL                      PO-ID is NULL
PO-ID or all mandatory
organization specific attribute are
required
Yes if Lead Organization PO-ID is
NULL
Yes if Lead Organization PO-ID is
NULL


Yes if Lead Organization PO-ID is
NULL
Yes for US/Canada/Australia and       2-letter state/province code
if Lead Organization PO-ID is         required for US/Canada, 2-3
NULL                                  letter code required for Australia

Yes if Lead Organization PO-ID is
NULL
Yes if Lead Organization PO-ID is     3-letter country code required
NULL
Yes if Lead Organization PO-ID is
NULL




                                      Institution, ordering group,
                                      repository, research based,
PO-ID or all person-specific          cooperative group, cancer center,
mandatory attributes
Yes if Principal Investigator PO-
ID is NULL


Yes if Principal Investigator PO-
ID is NULL
Yes if Principal Investigator PO-
ID is NULL


Yes if Principal Investigator PO-
ID is NULL

Yes for US/Canada/Australia and       2-letter state/province code
if Principal Investigator PO-ID is    required for US/Canada, 2-3
NULL                                  letter code required for Australia
Yes if Principal Investigator PO-
ID is NULL

Yes if Principal Investigator PO-                                           3-letter country code required
ID is NULL

Yes if Principal Investigator PO-
ID is NULL
Yes if Principal Investigator PO-
ID is NULL




Yes                                   Yes                                   National, Externally Peer-
                                                                            Reviewed, Institutional
PO-ID or all mandatory                PO-ID or all mandatory
organization specific attribute are   organization specific attribute are
required                              required
Yes if Organization PO-ID is          Yes if Organization PO-ID is
NULL                                  NULL

Yes if Organization PO-ID is          Yes if Organization PO-ID is
NULL                                  NULL

Yes if Organization PO-ID is          Yes if Organization PO-ID is
NULL                                  NULL
Yes if Organization PO-ID is          Yes if Organization PO-ID is
NULL and for                          NULL and for
US/Canada/Australia                   US/Canada/Australia
Yes if Organization PO-ID is          Yes if Organization PO-ID is
NULL                                  NULL

Yes if Organization PO-ID is          Yes if Organization PO-ID is
NULL                                  NULL
Yes if Organization PO-ID is          Yes if Organization PO-ID is
NULL                                  NULL
Yes: if NIH grant exists            Yes: if NIH grant exists            Refer Funding Mechanism in
                                                                        Valid Values worksheet.

Yes: if NIH grant exists            Yes: if NIH grant exists            Refer Institute Code in Valid
                                                                        Values worksheet.

Yes: if NIH grant exists            Yes: if NIH grant exists            format: 5 or 6 digits


Yes: if NIH grant exists            Yes: if NIH grant exists            Refer NCI Division/Program
                                                                        Code in Valid Values worksheet.
                                                                        Specify only the code.




Yes                                 Yes                                 In Review, Approved, Active,
                                                                        Closed to Accrual, Closed to
                                                                        Accrual and Intervention ,
                                                                        Temporarily Closed to Accrual,
                                                                        Temporarily Closed to Accrual
                                                                        and Intervention, Complete,
Yes if Current Trial Status is      Yes if Current Trial Status is      Administratively Complete are
Withdrawn, Temporarily Closed       Withdrawn, Temporarily Closed
to Accrual, Temporarily Closed to   to Accrual, Temporarily Closed to
Accrual and Intervention or         Accrual and Intervention or
Administratively Complete           Administratively Complete

Yes                                 Yes

Yes                                 Yes
Yes                     Yes                     Actual, Anticipated




Yes                     Yes




Yes                     Yes                     Actual, Anticipated




Yes: if IND/IDE trial   Yes: if IND/IDE trial   IND, IDE


Yes: if IND/IDE trial   Yes: if IND/IDE trial


Yes: if IND/IDE trial   Yes: if IND/IDE trial   CDER, CBER, CDRH


Yes: if IND/IDE trial   Yes: if IND/IDE trial   Investigator, Organization,
                                                Industry, NIH, NCI
Yes If IND/IDE trial AND             Yes If IND/IDE trial AND          Refer NIH Institution in Valid
(IND/IDE Holder Type) = NIH          (IND/IDE Holder Type) = NIH       Values worksheet.




Yes if IND/IDE trial AND If          Yes if IND/IDE trial AND If       Refer NCI Division/Program
(IND/IDE Holder Type) = NCI          (IND/IDE Holder Type) = NCI       Code in Valid Values worksheet.




Yes if IND/IDE trial                 Yes if IND/IDE trial              Yes, No


If (Has Expanded Access?) =          If (Has Expanded Access?) =       Available, No longer available,
Yes                                  Yes                               Temporarily not available,
                                                                       Approved for marketing



                                                                       Yes, No


Yes if ClinicalTrials.gov XML        Yes if ClinicalTrials.gov XML     see Oversight Authority tab
Required? is set to 'Yes'            Required? is set to 'Yes'
Yes ClinicalTrials.gov XML           Yes ClinicalTrials.gov XML        see Oversight Authority tab
Required? is set to 'Yes'            Required? is set to 'Yes'
Yes ClinicalTrials.gov XML           Yes ClinicalTrials.gov XML        Yes, No
Required? is set to 'Yes'            Required? is set to 'Yes'

Yes if FDA Regulatory                Yes if FDA Regulatory              Yes, No
Information Indicator is 'Yes' and   Information Indicator is 'Yes' and
ClinicalTrials.gov XML Required?     ClinicalTrials.gov XML Required?
is set to 'Yes'                      is set to 'Yes'
Yes if section 801 Indicator is      Yes if section 801 Indicator is    Yes, No
'Yes' and ClinicalTrials.gov XML     'Yes' and ClinicalTrials.gov XML
Required? is set to 'Yes'            Required? is set to 'Yes'



                                                                       Yes, No



Yes
Yes




Yes
Comments




O - original submission (including the first
submission to CTRP); A - amendment
submission to the already published trial in
CTRP; U - update to the CTRP trial.
Amendment submission can be accepted
only if the trial processing status is
'Abstraction Verified Response' or
'Abstraction Verified No Response'.
Update can be submitted for trials that
have been accepted or have processing
status other than 'Submitted' and
'Rejected'. See Processing Status
Transition tab for information about trial
processing statuses

This element is applicable to amendment
submission and update to the CTRP trials
only. This is the trial identifier assigned by
the CTRP. Amendment can only be
accepted for trials that have 'Abstraction
Verified Response' or 'Abstraction Verified
No Response' processing status in CTRP.
Update can be submitted for trials that
have 'Accepted' status and above.

Indicates whether XML generation for trial
submitting in ClinicalTrials.gov is required.
If Indicator is assigned to 'No', responsible
Party information and Regulatory
Information is not required (will be ignored
if provided). This value is ignored in
update submission

This element is applicable to amendment
submission only. Use amendment number
that is recorded in user's system.

This element is applicable to amendment
submission only. Use date of amendment
as documented in the amended protocol
document . Format mm/dd/yyyy.

AS IS in the protocol document &
assigned by the lead organization (unique
in the lead organization system)
Unique identifier assigned to the published
trials in PRS (ClinicalTrials.gov)

If more than one exists, provide them in
one column separated with semicolon (;)

Title from the protocol document




Currently only Interventional trials are
accepted




Use value 'Other' if Primary Purpose value
is 'Other' (this applies to interventional
trials only)
Provide description if Primary Purpose is
'Other' (col 13)


Will be recorded only if Phase value is NA.
Default: No
Include Phone Extension if any in the
same field. Use XXX-XXX-XXXX format
for USA and Canada



Ignored if ClinicalTrials.gov XML
Required? is set to 'No'

Used for defining contact type for the
Responsible Party Sponsor (see 27)


Applicable to the Responsible
Party=Sponsor Generic Contact only




Applicable to the Responsible
Party=Sponsor Personal Contact only




Applicable to the Responsible
Party=Sponsor Personal Contact only
Applicable to the Responsible
Party=Sponsor Personal Contact only




Applicable to the Responsible
Party=Sponsor Personal Contact only




Applicable to the Responsible
Party=Sponsor Personal Contact only




Applicable to the Responsible
Party=Sponsor Personal Contact only




Applicable to the Responsible
Party=Sponsor Personal Contact only




Applicable to the Responsible
Party=Sponsor Personal Contact only




Include Phone Extension if any in the
same field. Use XXX-XXX-XXXX format
for USA and Canada
Include Phone Extension if any in the
same field. Use XXX-XXX-XXXX format
for USA and Canada
Include Phone Extension if any in the
same field. Use XXX-XXX-XXXX format
for USA and Canada




Provide PO-ID or all organization related
mandatory attributes

Provide if PO-ID is NULL


Provide if PO-ID is NULL


Provide if PO-ID is NULL

Provide if PO-ID is NULL


Provide if PO-ID is NULL


Provide if PO-ID is NULL

Provide if PO-ID is NULL


Include Phone Extension if any in the
same field. Use XXX-XXX-XXXX format
for USA and Canada




Summary 4 element, no LOV exists,
codes are specific to cancer centers
If more than one grant is recorded provide
this value for all grants separated by
semicolon (;)
If more than one grant is recorded provide
this value for all grants separated by
semicolon (;)
If more than one grant is recorded provide
this value for all grants separated by
semicolon (;)
Defaults to N/A if not specified. If more
than one grant is recorded provide this
value for all grants separated by
semicolon (;)




1) Trials with current trial status
'Withdrawn' are not accepted for the
original submission. 2) Submission of
amendment or update to existing study
with Completed, Administratively
Completed, Withdrawn and Disapproved
current trialifstatus are not Status is 3)
Mandatory Current Trial accepted.
Withdrawn, Temporarily Closed to
Accrual, Temporarily Closed to Accrual
and Intervention or Administratively
Complete

Date when the status has came in effect.
Format: mm/dd/yyyy
Date that enrollment to the protocol
begins. Format: mm/dd/yyyy
Only current/past date (in respect to batch
upload date) is accepted for actual type
and only future date is accepted for
anticipated type. 'Anticipated' type is valid
for 'In Review' and 'Approved' and
'Withdrawn' current trial status only.
'Actual' type is valid for any other current
trial status besides 'In Review', 'Approved'
and 'Withdrawn'. For more information
check State-Dates tab in this file.




Date that the final subject was examined
or received an intervention for the
purposes of final collection of data for the
primary outcome, whether the clinical trial
concluded according to the prespecified
protocol or was terminated. Format:
mm/dd/yyyy


Only current/past date (in respect to batch
upload date) is accepted for actual type
and only future date is accepted for
anticipated type. 'Actual' type is valid for
'Administratively Complete' or 'Complete'
current trial statuses only. 'Anticipated'
type is valid for any other current trial
status besides 'Administratively Complete'
or 'Complete'. For more information check
State-Dates tab in this file.

If more than one IND/IDE is recorded
provide this value for all IND/IDE
separated by semicolon (;).
If more than one IND/IDE is recorded
provide this value for all IND/IDE
separated by semicolon (;)
If more than one IND/IDE is recorded
provide this value for all IND/IDE
separated by semicolon (;)
If more than one IND/IDE is recorded
provide this value for all IND/IDE
separated by semicolon (;)
If more than one IND/IDE is recorded
provide this value for all IND/IDE
separated by semicolon (;). If NIH
institution is not applicable to a single
IND/IDE, provide NA as replacement for
the value
If more than one IND/IDE is recorded
provide this value for all IND/IDE
separated by semicolon (;). If NCI
division/program is not applicable to a
single IND/IDE, provide NA as
replacement for the value
If more than one IND/IDE is recorded
provide this value for all IND/IDE
separated by semicolon (;).
If more than one IND/IDE is recorded
provide this value for all IND/IDE
separated by semicolon (;). If expanded
access is not applicable to a single
IND/IDE, provide NA as replacement for
the value
If more than one IND/IDE is recorded
provide this value for all IND/IDE
separated by semicolon (;). Default: 'No'
Ignored if ClinicalTrials.gov XML
Required? is set to 'No'
Ignored if ClinicalTrials.gov XML
Required? is set to 'No'
Must be 'Yes; if trial includes IND/IDE.
Ignored if ClinicalTrials.gov XML
Required? is set to 'No'
Must be not NULL if FDA Regulatory
Information Indicator is 'Yes'. Ignored if
ClinicalTrials.gov XML Required? is set to
'No'
Must be not NULL if section 801 Indicator
is 'Yes'. Delayed Posting Indicator is
applicable only to study that includes
device intervention. Ignored if
ClinicalTrials.gov XML Required? is set to
'No'
Ignored if ClinicalTrials.gov XML
Required? is set to 'No'


1) Include file extension. 2) If you have at
least two files with the same name,
rename files (ex. prefix unique trial
identifier to document name).          3)
Submit amended protocol for amendment
submission.
1) Include file extension. 2) if you have at
least two files with the same name,
rename files (ex. prefix unique trial
identifier to document name).          3)
Submit dummy file if IRB approval is not
required with the statement 'IRB' approval
is not required'.           4) Submit
dummy file with the following info: name of
Review Board (address, phone, email) and
Board Affiliation name in case of pre-IRB
approved studies submission. 5) One IRB
Approval is only needed.


1) Include file extension. 2) f you have at
least two files with the same name,
rename files (ex. prefix unique trial
identifier to document name).           3)
Requited if case of multi-site trial and if the
participation sites information is not
included in the protocol document. 4) If
participating site changes (recruitment
status, program code) or collaborator's
info change occur, submit this document
for amendment or update
1) Requited if is not included in the
protocol document.2) Include file
extension. 3) f you have at least two files
with the same name, rename files (ex.
prefix unique trial identifier to document
name).
1) Include file extension. 2) f you have at
least two files with the same name,
rename files (ex. prefix unique trial
identifier to document name).
1) This element is applicable to the
amendment only and includes the
changes that occurred in the protocol
document due to amendment. 2) Include
file extension. 3) f you have at least two
files with the same name, rename files
(ex. prefix unique trial identifier to
document name).
1) This element is applicable to the
amendment only and includes the protocol
document with highlighted changes from
the previous version. 2) Include file
extension. 3) f you have at least two files
with the same name, rename files (ex.
prefix unique trial identifier to document
name).
NOTE: These are the valid values for the data elements. They are presented in vertical format - no relation across


Funding                      Institute
Mechanism                    Code                      NCI Division/Program Code
B01                          AA                        CCR
B08                          AE                        CTEP

B09                          AF                        DCB

C06                          AG                        DCCPS
DP1                          AI                        DCEG

DP2                          AM                        DTP

DP3                          AO                        DCP

D43                          AR                        DEA

D71                          AT                        OD


E11                          BC                        OSB/SPOREs

F05                          BX                        CIP

F30                          CA                        CDP

F31                          CB                        TRP
F32                          CD                        RRP

F33                          CE                        N/A

F34                          CH
F37                          CI


F38                          CK


G07                          CL
G08                          CM
G11                          CN
G12                          CO


G13                          CP


G20                          CR


G94                          CT


HD4                          CU
HR!                          CX
                             DA
H13                          DC
H23                          DD
H25                          DE
H28   DK
H50   DP
H57   EB
H62   EH
H64   EM
H75   EP
H79   ES
I01   EY
KD1   FD
KL1   GD
KL2   GH
K01   GM
K02   GW
K05   HB
K06   HC
K07   HD
K08   HG
K12   HI
K14   HK
K18   HL
K21   HM
K22   HO
K23   HP
K24   HR
K25   HS
K26   HV
K30   HX
K99   HY
L30   IP
L32   JT
L40   LM
L50   MD
L60   MH
M01   MN
N01   NB
N02   NH
N03   NR
N43   NS
N44   NU
PL1   OA
PN1   OC
PN2   OD
P01   OF
P20   OH
P30   OL
P40   OR
P41   PC
P42   PH
P50   PR
P51   PS
P60   RD
P76   RX
RC1   SC
RC2   SF
RC3   SH
RC4   SM
RL1   SP
RL2   SU
RL5   TI
RL9   TP
RS1   TS
R00   WH
R01   RC
R03   RG
R04   RM
R06   RR
R08   TW
R13   WT
R15   VA
R17   WC
R18
R21
R24
R25
R30
R33
R34
R36
R37
R41
R42
R43
R44
R49
R55
R56
R90
SC1
SC2
SC3
S06
S10
S11
S21
S22
TL1
TU2
T01
T02
T03
T06
T09
T14
T15
T32
T34
T35
T36
T37
T42
T90
UA1
UC1
UC2
UC3
UC6
UC7
UD1
UE1
UE2
UH1
UH2
UH3
UL1
UR1
UR3
UR6
UR8
US3
US4
UT1
UT2
U01
U09
U10
U11
U13
U14
U17
U18
U19
U1A
U1Q
U1S
U1T
U1V
U21
U22
U23
U24
U27
U2G
U2R
U30
U32
U34
U36
U38
U41
U42
U43
U44
U45
U47
U48
U49
U50
U51
U52
U53
U54
U55
U56
U57
U58
U59
U60
U61
U62
U65
U66
U75
U79
U81
U82
U83
U84
U87
U88
U90
VF1
X01
X02
X06
X98
Y01
Y02
Z01
Z02
no relation across




            NIH Institution
            NEI-National Eye Institute
            NHLBI-National Heart, Lung, and Blood
            Institute
            NHGRI-National Human Genome Research
            Institute
            NIA-National Institute on Aging
            NIAAA-National Institute on Alcohol Abuse
            and Alcoholism
            NIAID-National Institute of Allergy and
            Infectious Diseases
            NIAMS-National Institute of Arthritis and
            Musculoskeletal and Skin Diseases
            NIBIB-National Institute of Biomedical
            Imaging and Bioengineering
            NICHD-Eunice Kennedy Shriver National
            Institute of Child Health and Human
            Development
            NIDCD-National Institute on Deafness and
            Other Communication Disorders
            NIDCR-National Institute of Dental and
            Craniofacial Research
            NIDDK-National Institute of Diabetes and
            Digestive and Kidney Diseases
            NIDA-National Institute on Drug Abuse
            NIEHS-National Institute of Environmental
            Health Sciences
            NIGMS-National Institute of General Medical
            Sciences
            NIMH-National Institute of Mental Health
            NINDS-National Institute of Neurological
            Disorders and Stroke
            NINR-National Institute of Nursing Research

            NLM-National Library of Medicine
            CIT-Center for Information Technology
            CSR-Center for Scientific Review
            FIC-John E. Fogarty International Center for
            Advanced Study in the Health Sciences
            NCCAM-National Center for Complementary
            and Alternative Medicine
            NCMHD-National Center on Minority Health
            and Health Disparities
            NCRR-National Center for Research
            Resources (NCRR
            CC-NIH Clinical Center
            OD-Office of the Director
            A            B              C            D            E            F             G
     Unique Trial   Submission   NCI Trial    ClinicalTrials. Amendment   Amendment   Lead
     Identifier     Type         Identifier   gov XML         Number      Date        Organization
                                              Required?                               Trial Identifier


1
     10             O                         Yes                                     53112

2
     1000           A            NCI-2009-    Yes          A1             39938       1234
                                 00001


3
     2001           O                         Yes                                     12345



4
     3000           O                         No                                      65432




5
     4000           O                         Yes                                     1233




6
     5000           U            NCI-2009-                                            12308
                                 00001




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16
     A   B   C   D   E   F   G
17
18
19
20
           H             I                     J                        K            L
     NCT         Other Trial   Title                             Trial Type    Primary
                 Identifier                                                    Purpose



1
     NCT000123   123;123-A     A Phase I study of Taxol in       Interventional Treatment
                               refractory leukemia in children
2
     NCT00045                  Phase III Study of Zoladex        Interventional Treatment
                               Adjuvant to Radiotherapy in
                               Unfavorable Prognosis
                               Carcinoma of the Prostate
3
                               A Phase I trial of Ifosfamide and Interventional Treatment
                               Taxol in refractory Pelvic
                               Malignancies

4
                               Phase III study of priming with  Interventional Treatment
                               granulocyte-macrophage colony
                               stimulating factor (rhu-gm-
                               csf)and of three induction
                               regimens in adult patients (over
                               55) with acute non-lymphocytic
5                              leukemia
                               Phase III Comparison of          Interventional Other
                               Methotrexate, Vinblastine,
                               Doxorubicin, and Cisplatin
                               (MVAC) vs. Doxorubicin and
                               Cisplatin (AC) in Women with
                               Advanced Primary or Recurrent
                               Metastatic Carcinoma of the
                               Uterine Endometrium
6
     NCT009876   321-12        An Open-Labeled, Non-             Interventional Treatment
                               Randomized Phase I Study of
                               Alvocidib (Flavopiridol)
                               Administered with Oxaliplatin
                               and Fluorouracil/Leucovorin in
                               Patients with Advanced Solid
 7                             Tumors
 8
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10
11
12
13
14
15
16
     H   I   J   K   L
17
18
19
20
             M          N              O              P        Q
     [Primary     [Primary     Phase       Pilot Trial?   [Sponsor]
     Purpose]     Purpose]                                Organization
     Additional   Other Text                              PO-ID
     Qualifier

1
                               I

2
                               III



3
                               I                          654512



4
                               III




5
     Other        Laboratory   NA          Yes            87654




6
                               I




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15
16
     M   N   O   P   Q
17
18
19
20
               R                  S                T                       U
     [Sponsor]             [Sponsor] Street [Sponsor] City   [Sponsor] State/Province
     Organization Name     Address



1
     Children's Oncology   2115 E           Rockville        MD
     Group                 Jefferson St
2
     Radiation Therapy     200 Water        New York         NY
     Oncology Group        Street


3




4




5




6




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13
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15
16
     R   S   T   U
17
18
19
20
                       V                  W                    X             Y
     [Sponsor] Zip/Postal code   [Sponsor] Country   [Sponsor] Email   [Sponsor]
                                                     Address           Phone



1
     20185                       USA                 test@cog.org      222-444-8888

2
     22102                       USA                 mailto@rtog.com   222-444-8888



3




4




5




6




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16
     V   W   X   Y
17
18
19
20
                Z         AA          AB           AC           AD           AE
     [Sponsor] TTY   [Sponsor]   [Sponsor]   Responsible   Sponsor      [Sponsor
                     FAX         URL         Party         Contact Type Contact] Title



1
                                             PI

2
                                             Sponsor       Personal



3
                                             Sponsor       Generic       Clinical Study
                                                                         Department


4




5
                                             Sponsor       Personal




6
                                             Sponsor       Generic       Director of
                                                                         Clinical Study
                                                                         Department



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10
11
12
13
14
15
16
     Z   AA   AB   AC   AD   AE
17
18
19
20
           AF              AG            AH               AI            AJ        AK          AL
     [Sponsor        [Sponsor     [Sponsor Contact] [Sponsor        [Sponsor [Sponsor    [Sponsor
     Contact] Person Contact]     Middle Name       Contact] Last   Contact] Contact]    Contact]
     PO-ID           First Name                     Name            Street   City        State/Provin
                                                                    Address              ce

1


2
     23456



3




4




5
                     Todd                           Wright          400 Main Handerson   TN
                                                                    St




6




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10
11
12
13
14
15
16
     AF   AG   AH   AI   AJ   AK   AL
17
18
19
20
          AM          AN         AO               AP            AQ         AR         AS
     [Sponsor     [Sponsor   [Sponsor   [Sponsor Contact]   [Sponsor   [Sponsor   [Sponsor
     Contact]     Contact]   Contact]   Phone               Contact]   Contact]   Contact]
     Zip/Postal   Country    Email                          TTY        FAX        URL
     code                    Address

1


2




3
                             mailto@gog. 240-345-4567
                             com


4




5
     20390        USA        twright@eso 607-123-1234
                             g.com




6
                             twright@eso 607-123-1234
                             g.com




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12
13
14
15
16
     AM   AN   AO   AP   AQ   AR   AS
17
18
19
20
         AT           AU              AV               AW                  AX             AY
     [Lead        [Lead          [Lead         [Lead Organization]   [Lead           [Lead
     Organization Organization   Organization] City                  Organization]   Organization]
     ]            ] Name         Street                              State/Provinc   Zip/Postal
     Organization                Address                             e               code
     PO-ID
1
                 Gynecologic 100 Main St        Fairfax              VA              22032
                 Oncology
2                Group
                 Children's  2115 E             Rockville            MD              20185
                 Oncology    Jefferson St
                 Group

3
                 North           100 Meadow Hartford                 CT              33333
                 Central         Rd
                 Cancer
                 Treatment
4                Group
     12345




5
                 Children's      2115 E         Rockville            MD              20185
                 Oncology        Jefferson St
                 Group




6




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10
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12
13
14
15
16
     AT   AU   AV   AW   AX   AY
17
18
19
20
              AZ                   BA                 BB            BC            BD            BE
     [Lead Organization]   [Lead Organization]   [Lead         [Lead         [Lead         [Lead
     Country               Email Address         Organization] Organization] Organization] Organization]
                                                 Phone         TTY           FAX           URL


1
     USA                   test@cog.org          222-444-
                                                 8888
2
     USA                   test@cog.org          222-444-
                                                 8888


3
     USA                   test@cog.org          222-444-
                                                 8888


4




5
     USA                   test@cog.org          222-444-
                                                 8888




6




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10
11
12
13
14
15
16
     AZ   BA   BB   BC   BD   BE
17
18
19
20
          BF               BG              BH               BI           BJ              BK              BL
     [Lead           [Principal      [Principal      [Principal    [Principal      [Principal      [Principal
     Organization]   Investigator]   Investigator]   Investigator] Investigator]   Investigator]   Investigator]
     Organization    Person PO-      First Name      Middle Name Last Name         Street          City
     Type            ID                                                            Address

1
     cooperative     1234
     group
2
     cooperative                     Miljenko        B             Pilepich        100 Village     Natick
     group                                                                         Hill Lane


3
     cooperative     87456
     group


4
     cooperative                     Jacob           J             Rowe            100 Old         Houston
     group                                                                         Meadow Rd




5
     cooperative     45689
     group




6




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10
11
12
13
14
15
16
     BF   BG   BH   BI   BJ   BK   BL
17
18
19
20
           BM              BN              BO              BP              BQ              BR              BS
     [Principal      [Principal      [Principal      [Principal      [Principal      [Principal      [Principal
     Investigator]   Investigator]   Investigator]   Investigator]   Investigator]   Investigator]   Investigator]
     State/Provinc   Zip/Postal      Country         Email           Phone           TTY             FAX
     e               code                            Address

1


2
     MA              01760           USA             MPilepich@m 111-111-
                                                     ednet.ucla.ed 1112
                                                     u

3




4
     TX              33323           USA             rowe@ramba 111-111-
                                                     m.health.gov. 1114
                                                     il



5




6




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12
13
14
15
16
     BM   BN   BO   BP   BQ   BR   BS
17
18
19
20
           BT             BU              BV            BW               BX             BY             BZ
     [Principal      Summary 4       [Summary 4     [Summary 4     [Summary 4     [Summary 4     [Summary 4
     Investigator]   Funding         Funding        Funding        Funding        Funding        Funding
     URL             Category        Sponsor/Sour   Sponsor/Sour   Sponsor/Sour   Sponsor/Sour   Sponsor/Sour
                                     ce]            ce]            ce] Street     ce] City       ce]
                                     Organization   Organization   Address                       State/Provinc
1                                    PO-ID          Name                                         e
                     Institutional                  NCI            2115 E         Rockville      MD
                                                                   Jefferson
2
                     Institutional                  NCI            2115 E         Rockville      MD
                                                                   Jefferson


3
                     Institutional                  NCI            2115 E         Rockville      MD
                                                                   Jefferson


4
                     Institutional                  NCI            2115 E         Rockville      MD
                                                                   Jefferson




5
                     Institutional                  NCI            2115 E         Rockville      MD
                                                                   Jefferson




6
                     Institutional                  NCI            2115 E         Rockville      MD
                                                                   Jefferson




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16
     BT   BU   BV   BW   BX   BY   BZ
17
18
19
20
           CA               CB             CC             CD             CE             CF             CG
     [Summary 4       [Summary 4     [Summary 4     [Summary 4     [Summary 4     [Summary 4     [Summary 4
     Funding          Funding        Funding        Funding        Funding        Funding        Funding
     Sponsor/Sour     Sponsor/Sour   Sponsor/Sour   Sponsor/Sour   Sponsor/Sour   Sponsor/Sour   Sponsor/Sour
     ce] Zip/Postal   ce ] Country   ce ] Email     ce ] Phone     ce ] TTY       ce ] FAX       ce ] URL
     code                            Address
1
     20852            USA            mailto@ctrp.o 111-111-
                                     rg            1111
2
     20852            USA            mailto@ctrp.o 111-111-
                                     rg            1111


3
     20852            USA            mailto@ctrp.o 111-111-
                                     rg            1111


4
     20852            USA            mailto@ctrp.o 111-111-
                                     rg            1111




5
     20852            USA            mailto@ctrp.o 111-111-
                                     rg            1111




6
     20852            USA            mailto@ctrp.o 111-111-
                                     rg            1111




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11
12
13
14
15
16
     CA   CB   CC   CD   CE   CF   CG
17
18
19
20
          CH        CI               CJ             CK            CL            CM              CN
     Program   [NIH Grant]   [NIH Grant]      [NIH Grant]   [NIH Grant]    Current Trial   Why Study
     Code      Funding       Institute Code   Serial        NCI            Status          Stopped?
               Mechanism                      Number        Division/Progr
                                                            am Code

1
               F34           AG               72345         CTEP           Complete

2
                                                                           Temporarily     Accrual target
                                                                           Closed to       was reached
                                                                           Accrual         for this phase
                                                                                           of the study
3
     IM        K08;CO6       HV;AO            97521;01234 CTEP;CTEP In Review
                                              5


4
                                                                           Approved




5
                                                                           Administrativ Closed
                                                                           ely Complete prematurely




6
     BR                                                                    Approved




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16
     CH   CI   CJ   CK   CL   CM   CN
17
18
19
20
          CO            CP            CQ            CR           CS            CT           CU
     Current Trial Study Start   Study Start   Primary      Primary       IND/IDE Type IND/IDE
     Status Date Date            Date Type     Completion   Completion                 Number
                                               Date         Date Type


1
     8/1/2010      2/1/2009      Actual        08/01/10     Actual

2
     8/2/2009      1/2/2009      Actual        10/02/11     Anticipated



3
     8/3/2009      12/3/2010     Anticipated   10/3/2011    Anticipated



4
     8/4/2009      12/4/2010     Anticipated   9/4/2012     Anticipated




5
     8/5/2009      1/5/2009      Actual        8/5/2009     Actual        IND;IND     67899;10,264




6
     8/1/2009      12/1/2010     Anticipated   12/1/2011    Anticipated




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10
11
12
13
14
15
16
     CO   CP   CQ   CR   CS   CT   CU
17
18
19
20
          CV        CW              CX           CY             CZ          DA          DB
     IND/IDE   IND/IDE       [IND/IDE]     [IND/IDE]      [IND/IDE]   [IND/IDE]   [IND/IDE]
     Grantor   Holder Type   NIH           NCI Division   Has         Expanded    Exempt
                             Institution   /Program       Expanded    Access      Indicator
                                                          Access?     Status

1


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5
     CDER;CDER NIH;NCI       NIA;NA        NA;DCP         No;Yes      NA;Approved Yes;Yes
                                                                      for marketing




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     CV   CW   CX   CY   CZ   DA   DB
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          DC           DD              DE            DF           DG           DH           DI
     Oversight    Oversight      FDA           Section 801   Delayed     Data         Protocol
     Authority    Authority      Regulatory    Indicator     Posting     Monitoring   Document
     Country      Organization   Information                 Indicator   Committee    File Name
                  Name           Indicator                               Appointed
                                                                         Indicator
1
     United States Federal       No                                      Yes          protocol_doc
                   Government                                                         ument_T10.d
2                                                                                     oc
     United States Federal       No                                      Yes          protocol_doc
                   Government                                                         ument_T1000
                                                                                      .doc

3
     United States Food and      Yes           Yes           No          Yes          protocol_doc
                   Drug                                                               ument_T2001
                   Administratio                                                      .doc
                   n
4
                                                                                      3000_protoco
                                                                                      l_document.d
                                                                                      oc



5
     United States Federal       No                                      Yes          4000_protoco
                   Government                                                         l_document.d
                                                                                      oc




6
     United States Federal       No                                      Yes
                   Government




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     DC   DD   DE   DF   DG   DH   DI
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           DJ           DK               DL          DM          DN             DO    DP
     IRB Approval Participating    Informed    Other Trial   Change       Protocol
     Document     Sites            Consent     Related       Memo         Highlight
     File Name    Document         Document    Document      Document     Document
                  File Name        File Name   File Name     Name         Name

1
     IRB_Approval Participating_ 10_Informed_ 10_Other_do
     .doc         Sites_T10.xls Consent.PDF cument.doc
2
     IRB_Approval Participating_                             Change_me
     _06082007.d Sites_T1000_                                mo_doc.doc
     oc           new.xls

3
     IRB_Approval Participating_ Informed_Co Other_docum
     _T2001.doc Sites_T2001. nsent_T2001. ent_T2001.do
                  xls            PDF         c

4
     3000_IRB_Ap 3000_Particip 3000_Informe 3000_Other_
     proval.doc  ating_Sites.xl d_Consent.P document.do
                 s              DF          c



5
     4000_IRB_Ap 4000_Particip 4000_Informe 4000_Other_
     proval.doc  ating_Sites.xl d_Consent.P document.do
                 s              DF          c




6




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     DJ   DK   DL   DM   DN   DO   DP
17
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     DQ   DR   DS   DT   DU   DV   DW




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     DQ   DR   DS   DT   DU   DV   DW
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     DX   DY   DZ   EA   EB   EC   ED




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     DX   DY   DZ   EA   EB   EC   ED
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     EE   EF   EG   EH   EI   EJ   EK




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     EE   EF   EG   EH   EI   EJ   EK
17
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20
     EL   EM   EN   EO   EP   EQ   ER




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4




5




6




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     EL   EM   EN   EO   EP   EQ   ER
17
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     ES   ET   EU   EV   EW   EX   EY




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     ES   ET   EU   EV   EW   EX   EY
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     EZ   FA   FB   FC   FD   FE   FF




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     EZ   FA   FB   FC   FD   FE   FF
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     FG   FH   FI   FJ   FK   FL   FM




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     FG   FH   FI   FJ   FK   FL   FM
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     FN   FO   FP   FQ   FR   FS   FT




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     FN   FO   FP   FQ   FR   FS   FT
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     FU   FV   FW   FX   FY   FZ   GA




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Illustration for assigning current status/status date, start and primary completion dates.
Diagram includes Current Trial Status line (top),
Start Date line with type (below the Current Trial Status line) and Primary Completion line (bottom)




1. Current trial status date must be past/current.
2. Actual start date type is valid for any current trial status besides 'In Review' and 'Approved'
3. Anticipated start date type is only valid for current trial status 'In Review' and 'Approved'
4. Anticipated start date type turns into actual start date type when current trial status becomes 'Active'.
 If current trial status is 'Active', start date must be the same as the current trial status date for the initial
or smaller than the current trial status date if the 'Active' status is the recurrent status.
5. Actual primary completion date type is only valid for current trial status 'Administratively Complete' or
6. Anticipated primary completion date type is valid for current trial status other than 'Administratively Co
 If current trial status is 'Complete' or 'Administratively Complete', primary completion date must be the s
7. Only current/past date (in respect to batch upload date) is accepted for actual type
and only future date (in respect to batch upload date) is accepted for anticipated type.
8. If the current trial status is Withdrawn, Temporarily Closed to Accrual, Temporarily Closed to Accrual
the reason 'Why Study Stopped?' must be provided.
primary completion dates.

imary Completion line (bottom)




 n Review' and 'Approved'
Review' and 'Approved'
current trial status becomes 'Active'.
 current trial status date for the initial study activation.
e recurrent status.
 tatus 'Administratively Complete' or 'Complete'
status other than 'Administratively Complete' or 'Complete'
 imary completion date must be the same or bigger than the date of the preceding current trial status date (if one exists).
 ed for actual type
 r anticipated type.
crual, Temporarily Closed to Accrual and Intervention or Administratively Complete
te (if one exists).
NCI Division/Program Code   Definition
CCR                         Center for Cancer Research
CTEP                        Cancer Therapy Evaluation Program

DCB                         Division of Cancer Biology
DCCPS                       Division of Cancer Control and Population
                            Sciences
DCEG                        Division of Cancer Epidemiology and
                            Genetics
DTP                         Developmental Therapeutics Program

DCP                         Division of Cancer Prevention
DEA                         Division of Extramural Activities

OD                          Office of the Director, NCI, NIH
OSB/SPOREs                  Organ Systems Branch (OSB) /Specialized
                            Programs of Research Excellence
                            (SPOREs)
CIP                         Cancer Imaging Program
CDP                         Cancer Diagnosis Program
TRP                         Translational Research Program
RRP                         Radiation Research Program
N/A                         Not applicable
Country                          3-letter code
AFGHANISTAN                      AFG
ALBANIA                          ALB
ALGERIA                          DZA
AMERICAN SAMOA                   ASM
ANDORRA                          AND
ANGOLA                           AGO
ANGUILLA                         AIA
ANTARCTICA                       ATA
ANTIGUA AND BARBUDA              ATG
ARGENTINA                        ARG
ARMENIA                          ARM
ARUBA                            ABW
AUSTRALIA                        AUS
AUSTRIA                          AUT
AZERBAIJAN                       AZE
BAHAMAS                          BHS
BAHRAIN                          BHR
BANGLADESH                       BGD
BARBADOS                         BRB
BELARUS                          BLR
BELGIUM                          BEL
BELIZE                           BLZ
BENIN                            BEN
BERMUDA                          BMU
BHUTAN                           BTN
BOLIVIA                          BOL
BOSNIA AND HERZEGOWINA           BIH
BOTSWANA                         BWA
BOUVET ISLAND                    BVT
BRAZIL                           BRA
BRITISH INDIAN OCEAN TERRITORY   IOT
BRUNEI DARUSSALAM                BRN
BULGARIA                         BGR
BURKINA FASO                     BFA
BURUNDI                          BDI
CAMBODIA                         KHM
CAMEROON                         CMR
CANADA                           CAN
CAPE VERDE                       CPV
CAYMAN ISLANDS                   CYM
CENTRAL AFRICAN REPUBLIC         CAF
CHAD                             TCD
CHILE                            CHL
CHINA                            CHN
CHRISTMAS ISLAND                 CXR
COCOS (KEELING) ISLANDS          CCK
COLOMBIA                         COL
COMOROS                          COM
CONGO                            COG
COOK ISLANDS                     COK
COSTA RICA                       CRI
COTE D'IVOIRE                    CIV
CROATIA (local name: Hrvatska)   HRV
CUBA                             CUB
CYPRUS                           CYP
CZECH REPUBLIC                   CZE
DENMARK                          DNK
DJIBOUTI                         DJI
DOMINICA                         DMA
DOMINICAN REPUBLIC               DOM
EAST TIMOR                       TMP
ECUADOR                          ECU
EGYPT                            EGY
EL SALVADOR                      SLV
EQUATORIAL GUINEA                GNQ
ERITREA                          ERI
ESTONIA                          EST
ETHIOPIA                         ETH
FALKLAND ISLANDS (MALVINAS)      FLK
FAROE ISLANDS                    FRO
FIJI                             FJI
FINLAND                          FIN
FRANCE                           FRA
FRANCE, METROPOLITAN             FXX
FRENCH GUIANA                    GUF
FRENCH POLYNESIA                 PYF
FRENCH SOUTHERN TERRITORIES      ATF
GABON                            GAB
GAMBIA                           GMB
GEORGIA                          GEO
GERMANY                          DEU
GHANA                            GHA
GIBRALTAR                        GIB
GREECE                           GRC
GREENLAND                        GRL
GRENADA                          GRD
GUADELOUPE                       GLP
GUAM                             GUM
GUATEMALA                        GTM
GUINEA                           GIN
GUINEA-BISSAU                    GNB
GUYANA                           GUY
HAITI                            HTI
HEARD AND MC DONALD ISLANDS      HMD
HOLY SEE (VATICAN CITY STATE)    VAT
HONDURAS                         HND
HONG KONG                        HKG
HUNGARY                          HUN
ICELAND                          ISL
INDIA                            IND
INDONESIA                        IDN
IRAN (ISLAMIC REPUBLIC OF)       IRN
IRAQ                             IRQ
IRELAND                                      IRL
ISRAEL                                       ISR
ITALY                                        ITA
JAMAICA                                      JAM
JAPAN                                        JPN
JORDAN                                       JOR
KAZAKHSTAN                                   KAZ
KENYA                                        KEN
KIRIBATI                                     KIR
KOREA, DEMOCRATIC PEOPLE'S REPUBLIC OF       PRK
KOREA, REPUBLIC OF                           KOR
KUWAIT                                       KWT
KYRGYZSTAN                                   KGZ
LAO PEOPLE'S DEMOCRATIC REPUBLIC             LAO
LATVIA                                       LVA
LEBANON                                      LBN
LESOTHO                                      LSO
LIBERIA                                      LBR
LIBYAN ARAB JAMAHIRIYA                       LBY
LIECHTENSTEIN                                LIE
LITHUANIA                                    LTU
LUXEMBOURG                                   LUX
MACAU                                        MAC
MACEDONIA, THE FORMER YUGOSLAV REPUBLIC OF   MKD
MADAGASCAR                                   MDG
MALAWI                                       MWI
MALAYSIA                                     MYS
MALDIVES                                     MDV
MALI                                         MLI
MALTA                                        MLT
MARSHALL ISLANDS                             MHL
MARTINIQUE                                   MTQ
MAURITANIA                                   MRT
MAURITIUS                                    MUS
MAYOTTE                                      MYT
MEXICO                                       MEX
MICRONESIA, FEDERATED STATES OF              FSM
MOLDOVA, REPUBLIC OF                         MDA
MONACO                                       MCO
MONGOLIA                                     MNG
MONTSERRAT                                   MSR
MOROCCO                                      MAR
MOZAMBIQUE                                   MOZ
MYANMAR                                      MMR
NAMIBIA                                      NAM
NAURU                                        NRU
NEPAL                                        NPL
NETHERLANDS                                  NLD
NETHERLANDS ANTILLES                         ANT
NEW CALEDONIA                                NCL
NEW ZEALAND                                  NZL
NICARAGUA                                    NIC
NIGER                                          NER
NIGERIA                                        NGA
NIUE                                           NIU
NORFOLK ISLAND                                 NFK
NORTHERN MARIANA ISLANDS                       MNP
NORWAY                                         NOR
OMAN                                           OMN
PAKISTAN                                       PAK
PALAU                                          PLW
PANAMA                                         PAN
PAPUA NEW GUINEA                               PNG
PARAGUAY                                       PRY
PERU                                           PER
PHILIPPINES                                    PHL
PITCAIRN                                       PCN
POLAND                                         POL
PORTUGAL                                       PRT
PUERTO RICO                                    PRI
QATAR                                          QAT
REUNION                                        REU
ROMANIA                                        ROM
RUSSIAN FEDERATION                             RUS
RWANDA                                         RWA
SAINT KITTS AND NEVIS                          KNA
SAINT LUCIA                                    LCA
SAINT VINCENT AND THE GRENADINES               VCT
SAMOA                                          WSM
SAN MARINO                                     SMR
SAO TOME AND PRINCIPE                          STP
SAUDI ARABIA                                   SAU
SENEGAL                                        SEN
SEYCHELLES                                     SYC
SIERRA LEONE                                   SLE
SINGAPORE                                      SGP
SLOVAKIA (Slovak Republic)                     SVK
SLOVENIA                                       SVN
SOLOMON ISLANDS                                SLB
SOMALIA                                        SOM
SOUTH AFRICA                                   ZAF
SOUTH GEORGIA AND THE SOUTH SANDWICH ISLANDS   SGS
SPAIN                                          ESP
SRI LANKA                                      LKA
ST. HELENA                                     SHN
ST. PIERRE AND MIQUELON                        SPM
SUDAN                                          SDN
SURINAME                                       SUR
SVALBARD AND JAN MAYEN ISLANDS                 SJM
SWAZILAND                                      SWZ
SWEDEN                                         SWE
SWITZERLAND                                    CHE
SYRIAN ARAB REPUBLIC                           SYR
TAIWAN, PROVINCE OF CHINA                      TWN
TAJIKISTAN                             TJK
TANZANIA, UNITED REPUBLIC OF           TZA
THAILAND                               THA
TOGO                                   TGO
TOKELAU                                TKL
TONGA                                  TON
TRINIDAD AND TOBAGO                    TTO
TUNISIA                                TUN
TURKEY                                 TUR
TURKMENISTAN                           TKM
TURKS AND CAICOS ISLANDS               TCA
TUVALU                                 TUV
UGANDA                                 UGA
UKRAINE                                UKR
UNITED ARAB EMIRATES                   ARE
UNITED KINGDOM                         GBR
UNITED STATES                          USA
UNITED STATES MINOR OUTLYING ISLANDS   UMI
URUGUAY                                URY
UZBEKISTAN                             UZB
VANUATU                                VUT
VENEZUELA                              VEN
VIET NAM                               VNM
VIRGIN ISLANDS (BRITISH)               VGB
VIRGIN ISLANDS (U.S.)                  VIR
WALLIS AND FUTUNA ISLANDS              WLF
WESTERN SAHARA                         ESH
YEMEN                                  YEM
YUGOSLAVIA                             YUG
ZAIRE                                  ZAR
ZAMBIA                                 ZMB
ZIMBABWE                               ZWE
Country         Country 3-letter code State/Province
UNITED STATES   USA
                                      Alabama
                                      Alaska
                                      Arizona
                                      Arkansas
                                      California
                                      Colorado
                                      Connecticut
                                      Delaware
                                      Florida
                                      Georgia
                                      Hawaii
                                      Idaho
                                      Illinois
                                      Indiana
                                      Iowa
                                      Kansas
                                      Kentucky
                                      Louisiana
                                      Maine
                                      Maryland
                                      Massachusetts
                                      Michigan
                                      Minnesota
                                      Mississippi
                                      Missouri
                                      Montana
                                      Nebraska
                                      Nevada
                                      New Hampshire
                                      New Jersey
                                      New Mexico
                                      New York
                                      North Carolina
                                      North Dakota
                                      Ohio
                                      Oklahoma
                                      Oregon
                                      Pennsylvania
                                      Rhode Island
                                      South Carolina
                                      South Dakota
                                      Tennessee
                                      Texas
                                      Utah
                                      Vermont
                                      Virginia
                                      Washington
                                      West Virginia
                                      Wisconsin
                                      Wyoming
CANADA    CAN
                Alberta
                British Columbia
                Manitoba
                New Brunswick
                Newfoundland and Labrador
                Northwest Territories
                Nova Scotia
                Nunavut
                Ontario
                Prince Edward Island
                Quebec
                Saskatchewan
                Yukon
AUSTRIA   AUT
                Australian Capital Territory
                New South Wales
                Northern Territory
                Queensland
                South Australia
                Tasmania
                Victoria
                Western Australia
2-3 letter state/province code   Old values

AL
AK
AZ
AR
CA
CO
CT
DE
FL
GA
HI
ID
IL
IN
IA
KS
KY
LA
ME
MD
MA
MI
MN
MS
MO
MT
NE
NV
NH
NJ
NM
NY
NC
ND
OH
OK
OR
PA
RI
SC
SD
TN
TX
UT
VT
VA
WA
WV
WI
WY
AB
BC
MB
NB
NL
NT
NS
NU
ON
PE
QC
SK
YT

ACT
NSW
NT
QLD
SA
TAS
VIC
WA
Oversight Authority Country   Oversight Authority Organization Name

Afghanistan                   Ministry of Public Health
Algeria                       Ministry of Health
Argentina                     Human Research Bioethics Committee
Argentina                     Administracion Nacional de Medicamentos,
                              Alimentos y Tecnologia Medica

Australia                     Department of Health and Ageing
                              Therapeutic Goods Administration
Australia                     Human Research Ethics Committee
Australia                     National Health and Medical Research
                              Council
Austria                       Ethikkommission
Austria                       Agency for Health and Food Safety
Austria                       Federal Ministry for Health and Women
Austria                       Federal Office for Safety in Health Care
Bangladesh                    Bangladesh Medical Research Council
Bangladesh                    Directorate of Drug Administration
Bangladesh                    Ethical Review Committee
Belarus                       Ministry of Health
Belgium                       Institutional Review Board
Belgium                       Directorate general for the protection of
                              Public health: Medicines
Belgium                       Federal Agency for Medicinal Products and
                              Health Products
Belgium                       Ministry of Social Affairs, Public Health and
                              the Environment
Belgium                       The Federal Public Service (FPS) Health,
                              Food Chain Safety and Environment
Bolivia                       Ethics Committee
Bolivia                       Ministry of Health
Brazil                        National Health Surveillance Agency
Brazil                        Ministry of Health
Brazil                        National Committee of Ethics in Research
Bulgaria                      Ministry of Health
Bulgaria                      Bulgarian Drug Agency
Burkina Faso                  Ministry of Health
Burkina Faso                  Ministry for Higher Education and Research

Cambodia                      Ministry of Health
Cameroon                      Ministry of Public Health
Canada                        Canadian Institutes of Health Research
Canada                        Ethics Review Committee
Canada                        Health Canada
Canada                        Ministry of Health & Long Term Care, Ontario

Chile                         Comisi?n Nacional de Investigaci?n
                              Cient?fica y Tecnol?gica
Chile                         Instituto de Salud Publica de Chile
China                         Ethics Committee
China                         Ministry of Health
China                         State Food and Drug Administration
Colombia                      INVIMA Instituto Nacional de Vigilancia de
                              Medicamentos y Alimentos
Colombia             Institutional Review Board
Croatia              Minister of Science, Education and Sports
Croatia              Ministry of Health and Social Care
Czech Republic       Ethics Committee
Czech Republic       State Institute for Drug Control
Denmark              Danish Dataprotection Agency
Denmark              Danish Medicines Agency
Denmark              Ethics Committee
Denmark              National Board of Health
Denmark              The Danish National Committee on
                     Biomedical Research Ethics
Denmark              The Ministry of the Interior and Health
Denmark              The Regional Committee on Biomedical
                     Research Ethics
Dominican Republic   Secretar?a del Estado de Salud P?blica y
                     Asistencia Social (SESPAS)
Ecuador              Public Health Ministry
Egypt                Institutional Review Board
Egypt                Ministry of Health and Population
Estonia              The State Agency of Medicine
Ethiopia             Ethiopia Science and Technology
                     Commission
Finland              Ethics Committee
Finland              Ministry of Social Affairs and Health
Finland              National Agency for Medicines
France               Afssaps - French Health Products Safety
                     Agency
France               Direction G?n?rale de la Sant?
France               French Data Protection Authority
France               Institutional Ethical Committee
France               Ministry of Health
France               National Consultative Ethics Committee for
                     Health and Life Sciences
Gambia               Department of State for Health and Social
                     Welfare
Gambia               MRC Ethics Committee
Georgia              Ministry of Health
Germany              Federal Ministry of Food, Agriculture and
                     Consumer Protection
Germany              Federal Ministry of Education and Research

Germany              Federal Institute for Drugs and Medical
                     Devices
Germany              Ethics Commission
Germany              Paul-Ehrlich-Institut
Ghana                Committee on Human Research
Ghana                Ministry of Health
Greece               National Organization of Medicines
Greece               Ethics Committee
Greece               Ministry of Health and Welfare
Guinea-Bissau        Ministry of Health
Hong Kong            Joint CUHK-NTEC Clinical Research Ethics
                     Committee
Hong Kong            Ethics Committee
Hong Kong            Department of Health
Hungary         National Institute of Pharmacy
Iceland         Ministry of Health and Social Security
Iceland         Icelandic Medicines Control Agency
India           Science and Engineering Research Council

India           Institutional Review Board
India           Ministry of Science and Technology
India           Ministry of Health
India           Department of Atomic Energy
India           Drugs Controller General of India
India           Indian Council of Medical Research
Ireland         Ministry of Health
Ireland         Medical Ethics Research Committee
Ireland         Irish Medicines Board
Israel          Ethics Commission
Israel          Ministry of Health
Israel          Israeli Health Ministry Pharmaceutical
                Administration
Israel          The Israel National Institute for Health Policy
                Research and Health Services Research

Italy           Ministry of Health
Italy           National Monitoring Centre for Clinical Trials -
                Ministry of Health
Italy           Ethics Committee
Italy           National Institute of Health
Italy           National Bioethics Committee
Italy           The Italian Medicines Agency
Jamaica         Ministry of Health
Japan           Foundation for Biomedical Research and
                Innovation
Japan           Pharmaceuticals and Medical Devices
                Agency
Japan           Ministry of Health, Labor and Welfare
Japan           Ministry of Education, Culture, Sports,
                Science and Technology
Japan           Institutional Review Board
Jordan          Ethical Committee
Kazakhstan      Ethical Commission
Kenya           Ethical Reveiw Committee
Kenya           Institutional Review Board
Kenya           Ministry of Health
Latvia          State Agency of Medicines
Lebanon         Ministry of Public Health
Lebanon         Institutional Review Board
Liechtenstein   Control Authority for Medicinal Products
Lithuania       Bioethics Committee
Lithuania       State Medicine Control Agency - Ministry of
                Health
Macedonia       Ethics Committee
Malawi          National Health Sciences Research
                Committee
Malawi          College of Medicine Research and Ethics
                Committee
Malaysia        Ministry of Health
Mali          Ministry of Health
Mauritius     Ministry of Health and Quality of Life
Mexico        National Council of Science and Technology

Mexico        Ethics Committee
Mexico        Federal Commission for Protection Against
              Health Risks
Mexico        Ministry of Health
Mexico        National Institute of Public Health, Health
              Secretariat
Mexico        Federal Commission for Sanitary Risks
              Protection
Morocco       Ministry of Public Health
Mozambique    Ministry of Health (MISAU)
Netherlands   The Central Committee on Research
              Involving Human Subjects (CCMO)
Netherlands   Dutch Health Care Inspectorate
Netherlands   Medical Ethics Review Committee (METC)
Netherlands   Medicines Evaluation Board (MEB)
Netherlands   Independent Ethics Committee
New Zealand   Health Research Council
New Zealand   Food Safety Authority
New Zealand   Health and Disability Ethics Committees
New Zealand   Institutional Review Board
New Zealand   Medsafe
Nigeria       The National Agency for Food and Drug
              Administration and Control
Norway        Data Inspectorate
Norway        The National Committees for Research
              Ethics in Norway
Norway        Norwegian Medicines Agency
Norway        Norwegian Institute of Public Health
Norway        Directorate for Health and Social Affairs
Norway        Norwegian Social Science Data Services
Pakistan      Ministry of Health
Pakistan      Research Ethics Committee
Panama        Ministry of Health
Peru          Ethics Committee
Peru          Ministry of Health
Peru          General Directorate of Pharmaceuticals,
              Devices, and Drugs
Philippines   Bureau of Food and Drugs
Philippines   Department of Health
Poland        Ministry of Scientific Research and
              Information Technology
Poland        Drug Institute
Poland        Ministry of Health
Poland        Office for Registration of Medicinal Products,
              Medical Devices and Biocidal Products

Portugal      Ethics Committee for Clinical Research
Portugal      National Pharmacy and Medicines Institute

Portugal      Health Ethic Committee
Romania       National Medicines Agency
Romania        State Institute for Drug Control
Saudi Arabia   Research Advisory Council
Saudi Arabia   Ministry of Health
Senegal        Ministere de la sante
Serbia         Ethics Committee
Sierra Leone   Ministry of Health and Sanitation
Singapore      Health Sciences Authority
Singapore      Domain Specific Review Boards
Singapore      Clinical Trials & Epidemiology Research Unit
               (CTERU)
Slovenia       Agency for Medicinal Products - Ministry of
               Health
Slovenia       Ministry of Health
South Africa   National Health Research Ethics Council
South Africa   Medicines Control Council
South Africa   Department of Health
Spain          Ministry of Health
Spain          Spanish Agency of Medicines
Spain          Ministry of Health and Consumption
Spain          Comit? ?tico de Investigaci?n Cl?nica
Spain          Ethics Committee
Sri Lanka      Ministry of Healthcare & Nutrition
Sudan          Ministry of Health
Sweden         Medical Products Agency
Sweden         The National Board of Health and Welfare
Sweden         Swedish National Council on Medical Ethics

Sweden         Regional Ethical Review Board
Sweden         Institutional Review Board
Switzerland    Ethikkommision
Switzerland    Federal Office of Public Health
Switzerland    Swissmedic
Switzerland    Laws and standards
Taiwan         Department of Health
Taiwan         National Bureau of Controlled Drugs
Taiwan         Institutional Review Board
Tanzania       National Institute for Medical Research
Tanzania       Food & Drug Administration
Tanzania       Ministry of Health
Thailand       Ethical Committee
Thailand       Khon Kaen University Ethics Committee for
               Human Research
Thailand       Food and Drug Administration
Thailand       Ministry of Public Health
Tunisia        Office of Pharmacies and Medicines
Tunisia        Ministry of Public Health
Turkey         Ethics Committee
Turkey         Ministry of Health
Uganda         Research Ethics Committee
Uganda         Ministry of Health
Uganda         National Council for Science and Technology

Ukraine        State Pharmacological Center - Ministry of
               Health
Ukraine        Ministry of Health
United Arab Emirates   General Authority for Health Services for Abu
                       Dhabi
United Arab Emirates   Drug Control Department - Medicines and
                       Pharmacy Control - Ministry of Health
United Kingdom         Food Standards Agency
United Kingdom         Medicines and Healthcare Products
                       Regulatory Agency
United Kingdom         Research Ethics Committee
United Kingdom         National Health Service
United Kingdom         Department of Health
United States          Federal Government
United States          Institutional Review Board
United States          Food and Drug Administration
Zambia                 Research Ethics Committee
Zambia                 Ministry of Health
Zimbabwe               Medical Research Council

				
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